Hydrophilic medical device assembly

Abstract

A medical device assembly comprises a medical device, such as a urinary catheter, comprising an insertable part and a non-insertable part. The insertable part comprises an elongate shaft provided with a hydrophilic coating or surface. The assembly further comprises a wetting fluid compartment arranged to encircle at least a part of the medical device, and preferably at least a part of the non-insertable part, and an aqueous fluid arranged in the wetting fluid compartment. At least one of the aqueous fluid and the hydrophilic coating or surface comprises at least one surfactant. The hydrophilic coating or surface is maintained essentially separated from the aqueous fluid, and arranged to become wetted by movement of the elongate shaft through the wetting fluid compartment.

What is claimed is: 
     
         1 . A medical device assembly comprising:
 a medical device comprising an insertable part and a non-insertable part, wherein the insertable part comprises an elongate shaft provided with a hydrophilic coating or surface;   a wetting fluid compartment arranged to encircle at least a part of the medical device; and   an aqueous fluid arranged in the wetting fluid compartment, wherein at least one of the aqueous fluid and the hydrophilic coating or surface comprises at least one surfactant, wherein a total concentration of the at least one surfactant is in a range of 0.01-1 wt % of a liquid phase;   wherein the hydrophilic coating or surface is maintained essentially separated from the aqueous fluid, and arranged to become wetted by movement of the elongate shaft through the wetting fluid compartment.   
     
     
         2 . The medical device assembly of  claim 1 , wherein the wetting fluid compartment is arranged to encircle at least a part of the non-insertable part of the medical device. 
     
     
         3 . The medical device assembly of  claim 1 , wherein the at least one surfactant is an organic component and is amphiphilic. 
     
     
         4 . The medical device assembly of  claim 1 , wherein the at least one surfactant contains both hydrophobic groups. 
     
     
         5 . The medical device assembly of  claim 4 , wherein the at least one surfactant includes a long alkyl chain attached to hydrophilic or water solubility enhancing functional groups. 
     
     
         6 . The medical device assembly of  claim 4 , wherein the at least one surfactant contains both a water-insoluble or oil-soluble component and a water-soluble component. 
     
     
         7 . The medical device assembly of  claim 1 , wherein a total concentration of surfactant(s) is in a range of 0.003-0.6 mM of a liquid phase. 
     
     
         8 . The medical device assembly of  claim 1 , wherein the aqueous fluid further includes a polyol and/or a low molecular weight hydrophilic polymer. 
     
     
         9 . The medical device assembly of  claim 8 , wherein the aqueous fluid includes a relative amount of polyol and/or low molecular weight hydrophilic polymer in a range of 0.01-20 wt %. 
     
     
         10 . The medical device assembly of  claim 8 , wherein the aqueous fluid includes a relative amount of polyol and/or low molecular weight hydrophilic polymer in a range of 0.1-10wt %. 
     
     
         11 . The medical device assembly of  claim 1 , wherein the at least one surfactant is a non-ionic surfactant. 
     
     
         12 . The medical device assembly of  claim 1 , wherein the medical device is a catheter. 
     
     
         13 . The medical device assembly of  claim 1 , wherein the medical device is a urinary catheter. 
     
     
         14 . The medical device assembly of  claim 1 , further comprising a package accommodating the wetting fluid compartment and at least the insertable part of the medical device. 
     
     
         15 . The medical device assembly of  claim 1 , wherein the wetting fluid compartment is fixedly arranged in a package, wherein extraction of the medical device from the package simultaneously provides a movement of the elongate shaft through the wetting fluid compartment, thereby wetting the hydrophilic coating or surface. 
     
     
         16 . The medical device assembly of  claim 1 , wherein the wetting fluid compartment is releasable from a package. 
     
     
         17 . The medical device assembly of  claim 1 , wherein the medical device is a catheter comprising at least one drainage opening arranged in a sidewall of the elongate shaft, wherein the wetting fluid compartment has a height in a longitudinal direction of the catheter exceeding a length of the at least one drainage opening in the longitudinal direction of the catheter. 
     
     
         18 . The medical device assembly of  claim 1 , wherein the medical device is a catheter comprising at least two drainage openings arranged in a sidewall of the elongate shaft, wherein the wetting fluid compartment has a height in a longitudinal direction of the catheter exceeding a length between ends of the at least two drainage openings being farthest apart in the longitudinal direction of the catheter. 
     
     
         19 . The medical device assembly of  claim 1 , wherein at least one breakable seal is provided between the wetting fluid compartment and the elongate shaft or wherein two breakable seals are provided between the wetting fluid compartment and the elongate shaft, provided on opposite sides of the wetting fluid compartment. 
     
     
         20 . The medical device assembly of  claim 1 , wherein the wetting fluid compartment comprises an amount of the aqueous fluid in a range of 0.5-5 ml, wherein the wetting fluid compartment comprises an amount of the aqueous fluid in a range of 1-4 ml, wherein a height of a level of wetting fluid within the wetting fluid compartment is at least 2 cm.